Scientific Studies Addressing BGMS and CGM Accuracy Presented at the American Diabetes Association's 77th Scientific Sessions

          This week at the American Diabetes Association 77th Scientific Sessions, data were presented from three studies that assessed the accuracy and analytical performance of blood glucose monitoring systems (BGMS) and continuous glucose monitoring (CGM) systems. Posters from two investigator initiated studies presented the accuracy data of various BGMS, while another poster, presented by Ascensia, described a new method for evaluating the analytical performance of CGM systems. The American Diabetes Association's 77th Scientific Sessions are taking place in San Diego, California from June 9-13, 2017.

          The lead investigator for the above mentioned investigator initiated studies, Dr. Guido Freckmann (Institut fuer Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH), presented two posters (117-LB and 915-P). One of these posters presented an evaluation of five BGMSs, including the CONTOUR(R)NEXT ONE system, by applying the ISO 15197:2013 accuracy criteria (95% or more test results must fall within plus or minus15 mg/dL or plus or minus15% at glucose concentrations <100 mg/dL or greater than or equal to 100 mg/dL respectively, and 99% or more of test results must fall within Zones A and B of the Consensus Error Grid for Type 1 diabetes).[1] The other poster presented an evaluation of four BGMSs, including the CONTOUR(R)PLUS ONE system, using the same ISO 15197:2013 accuracy criteria.[2] In both studies the data were obtained from 100 people with diabetes who had not used their assigned BGMS before. In each study, the subjects performed their own measurements and their readings were compared to a reference method. In these studies, both the CONTOUR(R)NEXT ONE and CONTOUR(R)PLUS ONE systems were shown to be highly accurate in the hands of lay-users.

          In the study that included the CONTOUR(R)NEXT ONE BGMS, four of the five BGMS fulfilled the user performance criteria of ISO 15197:2013, but differences were observed in the percentages of results within the accuracy limit. 100% of results for the CONTOUR(R) NEXT ONE BGMS in the hands of lay-users fell within the accepted ISO 15197:2013 accuracy criteria. The percentages of test results that fell within these accuracy criteria for the other systems in the study were 96% for the Accu-Chek(R) Aviva Connect, 95% for the FreeStyle(R) Freedom Lite, 95% for the GlucoMen(R) Areo and 93% for the OneTouch(R) Verio. None of the results provided by each system was found to be clinically unacceptable.

          In the study that included the CONTOUR(R)PLUS ONE BGMS, three of the four BGMS fulfilled the user performance criteria of ISO 15197:2013. 100% of results for the CONTOUR (R)PLUS ONE BGMS in the hands of lay-users fell within the accepted ISO 15197:2013 accuracy criteria and 99% were within the stricter criteria of plus or minus10 mg/dL and plus or minus10% for glucose concentrations <100 mg/dL and greater than or equal to100 mg/dL, respectively. The percentages of test results that fell within the ISO 15197:2013 accuracy criteria for the other systems in the study were 96% for the Accu-Chek(R) Performa Connect, 98% for the FreeStyle(R) Optium Neo and 92% OneTouch(R) Select Plus. All results provided by all systems were found to be clinically acceptable.

          Dr. Freckmann noted that "The accuracy of blood glucose monitoring systems continues to be critical for people with diabetes. They must be able to trust the readings they receive to enable them to make the correct decisions for the management of their condition. To achieve comparable performance in the hands of people with diabetes and healthcare professionals, blood glucose monitoring systems should be easy to use and resistant to errors."

          Funding for the investigator initiated studies and support for writing were provided by Ascensia Diabetes Care Germany GmbH.

          As for the methodological study presented by Pardo et al.[3], this poster showed that an error probability calculation, facilitated by the gamma distribution model, may be used in addition to MARD to provide a more informative tool for assessing the accuracy and analytical performance of CGM systems.

          The CONTOUR(R) NEXT ONE system is available in the U.S. and various European countries where the CONTOUR(R)NEXT test strips are available. The CONTOUR(R)PLUS ONE system has been launched in selected countries where the CONTOUR(R)PLUS test strips are available. Both systems are designed to connect via Bluetooth(R) technology to the CONTOUR(TM) DIABETES app, which is available for download from the Apple App Store (iOS) and Google Play (Android).